Re: CMS-4159-P, Contract
Year 2015 Policy and Technical Changes to the Medicare
Advantage and the Medicare Prescription Drug Benefit
Programs

Dear Administrator Tavenner:

The Cancer Leadership Council, including the undersigned
cancer patient, health professional, and research
organizations, urges that the Centers for Medicare &
Medicaid Services (CMS) reconsider the new policy on
classes of clinical concern that has been proposed for
Medicare Part D beginning in contract year
2015. Removing three classes of drugs from
“protected classes” status in 2015 and following years
is not in the best interest of individuals with cancer
or other serious illnesses who depend on ready access to
prescription drugs.

From the initial implementation of Medicare Part D, the
Cancer Leadership Council has recommended in the
strongest possible terms that cancer patients have
access to all drugs in the class of antineoplastic
agents. Cancer drugs are not readily
interchangeable, and decisions about appropriate therapy
for a cancer patient may be driven by information about
the specific mutation associated with an individual’s
cancer. In addition, cancer patients may require
access to combination therapies, combining two or more
cancer drugs in a drug regimen, and may require access
to several different chemotherapy agents over the course
of their disease. Anything less than access to
“all or substantially all” cancer drugs would threaten
the quality of care provided to Medicare
beneficiaries. This has always been true, but
access to all cancer drugs is even more important as we
move toward “targeted” or “personalized” cancer
treatment. The protected classes policy that has
been in place in Medicare Part D, which requires that
all or substantially all drugs in a class be covered,
has generally ensured Medicare beneficiaries diagnosed
with cancer access to the drug therapies they need.

CMS has concluded that antineoplastics meet the two
criteria for a class of drugs to be considered a class
of clinical concern. The agency would
require that: 1) hospitalization, disability, or death
is likely to result if administration of a drug in the
class does not occur in less than seven days, and 2)
more specific formulary standards cannot address the
matter of access to drugs in the class “due to the
diversity of disease or condition manifestations and
associated specificity or variability of drug therapies
necessary to treat such manifestations.” The first
criterion is dangerously restrictive, and we are
concerned that its application in future contract years
would result in the elimination of protected status for
antineoplastics.

In addition, as advocates for cancer patients, we have
concerns about the elimination of protected status for
other drug classes. Cancer patients often have
serious and significant co-morbidities that require
treatment, and the protected classes policy has helped
to ensure that they have appropriate access not only to
antineoplastics but also to supportive care
medications. For example, many cancer patients are
prescribed antidepressants, and proper care requires
access to all of the drugs in that class to protect
against dangerous drug interactions.

We understand that the decision to reconsider the
protected classes of drugs was driven in part by
a desire to increase the ability of plan issuers to
negotiate lower drug prices. We offer a caution
about attempting to achieve program savings through this
policy change. We believe that there will be a
financial burden for patients and also for plan issuers
associated with the appeals that will be pursued if the
protected classes are limited, in addition to the
significant personal burden that will be placed on
Medicare beneficiaries who find coverage appeals
processes sometimes unresponsive and lengthy. In
addition, delay in access to appropriate therapy may
result in increased utilization of other health care
services, undermining any attempt to save money through
more restricted formularies in Medicare Part D.

We strongly recommend that CMS abandon its decision to
eliminate the protected classes of antidepressants,
immunosuppressants, and antipsychotics and also
reconsider the criteria for establishing a class of
clinical concern.